Cerezyme Special Precautions

General: In <1% of the patient population, pulmonary hypertension and pneumonia have also been observed during treatment with Cerezyme. Pulmonary hypertension and pneumonia are known complications of Gaucher disease and have been observed both in patients receiving and not receiving Cerezyme. No causal relationship with Cerezyme has been established. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.
Therapy with Cerezyme should be directed by physicians knowledgeable in the management of patients with Gaucher disease.
Caution may be advisable in administration of Cerezyme to patients previously treated with Ceredase and who have developed antibody to or who have exhibited symptoms of hypersensitivity to Ceredase.
Carcinogenicity, Mutagenicity & Impairment of Fertility: Studies have not been conducted in either animals or humans to assess the potential effects of Cerezyme on carcinogenesis, mutagenesis or impairment of fertility.
Use in Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with Cerezyme. It is also not known whether Cerezyme can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Cerezyme should not be administered during pregnancy except when the indication and need are clear and the potential benefit is judged by the physician to substantially justify the risk.
Use in Lactation: It is not known whether Cerezyme is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cerezyme is administered to a nursing woman.
Use in Children: The safety and effectiveness of Cerezyme have been established in patients between 2-6 years. Use of Cerezyme in this age group is supported by evidence from adequate and well-controlled studies of Cerezyme and Ceredase in adults and pediatric patients, with additional data obtained from the medical literature and from long-term post-marketing experience. Cerezyme has been administered to patients <2 years; however, the safety and effectiveness in patients <2 years have not been established.